Body-retained catheter

ABSTRACT

An improved Foley-type catheter which is inflated through the drainage lumen. One-way valves separating both the retention balloon and the drainage lumen eyes from the drainage lumen permit a permanent, flexible and unobstructed construction of the catheter which thus lacks side arms and separate inflation lumen. An alternative arrangement provides for both inflation and deflation of the balloon through both the drainage lumen and a short passageway in the distal end of the catheter.

United States Pate Dye et al.

[451 Apr. 10, 1973 1 BODY-RETAINED CATHETER [75] Inventors: John F. Dye; William J. Binard,

both of Barrington, 111.

[73] Assignec: The Kendall Mass.

22 Filed: ()ct.7, 1971 21 App1.No.: 187,370

ompany, Boston,

[52] US. Cl. ..128/349 BV, 128/350, 128/246 [51] Int. Cl. .A6lm 25/00, A6lm 31/00, A611) 17/34 [58] Field of Search 128/348, 246, 349,

[56] 1 References Cited UNITED STATES PATENTS Doherty ..128/349 BV Doherty 128/349 BV 3,460,541 8/1969 Doherty .128/349 13V 3,482,576 12/1969 Ericson et a1. 128/349 BV 3,565,079 2/1971 Jackson 128/351 3,575,658 7/1972 Taylor 128/349 BV Primary Examiner-A1drich F. Medbery Attorney-Rowland V. Patrick 57] ABSTRACT An improved Foley-type catheter which is inflated through the drainage lumen. One-way valves separating both the retention balloon and the drainage lumen eyes from the drainage lumen permit a permanent,

flexible and unobstructed construction of the catheter which thus lacks side arms and separate inflation lumen. An alternative arrangement provides for both inflation and deflation of the balloon through both the drainage lumen and a short passageway in the distal end of the catheter.

17 Claims, 11 Drawing Figures PATENTED APR 1 0 9 5 SHEET 1 OF 2 FIG 3 FIG 2 FIG I BACKGROUND OF THE INVENTION Catheters are-commonly retained in body cavities by means of inflatable retention balloons mounted at the distal end. US. Pat. No. 3,190,291 is representative of catheters of this type, such catheters heretofore generally being characterized by an inflation lumen mounted adjacent to the drainage lumen and carrying the inflating fluid or medium to the retention balloon. The disadvantage of such construction arises from the fact that the total diameter of a catheter is limited by the size of the duct in which it is to be placed. The addition of an inflation lumen therefore reduces the cross sectional area of the drainage lumen from what it would otherwise have been in the absence of such an inflation lumen. Since the walls of the inflation lumen must be sufficiently substantial to sustain the relatively high pressures involved in inflating the retention balloon, the diameter of the inflation lumen is not of insignificant proportion to the total diameter of the catheter.

Thus, the use of an inflation lumen has reduced the cross sectional area available for the drainage lumen. This reduction in size of the drainage lumen in turn results in slower drainage and the greater likelihood of deposits in the drainage lumen building up to the point where drainage is cutoff.

A further disadvantage in catheters having a separate inflation lumen is that the proximal end of necessity must have a shape which departs from concentricity with the axis of the drainage lumen. For example, frequently the inflation lumen terminates at the proximal end in a separate arm. Such construction has the disadvantage in suprapubic catheters of requiring a slot in the trocar, which slot in turn tends to cause leakage when the catheter is being inserted into the body.

Further complications which are involved concern flexibility and ease of use. The urethral canal, particularly in the male, is a tortuous path substantially departing from linearity. Thus, catheters intended for use in urethras should be flexible.

SUMMARY OF THE INVENTION The disclosure relates to an improved balloon retained body catheter or drainage device, and particularly the structure utilized in inflating the retaining balloon. Thus, there is provided an improved flexible body cavity liquid drainage device having a proximal end, a distal end, at least one drainage eye in said distal end through which liquid enters the drainage device from the body cavity, a liquid drainage lumen extending from the eye to the proximal end, and inflatable retaining means for retaining the distal end within the body cavity. The improvement features means for inflating the retaining means by fluid flowing through the drainage lumen from the proximal end, the inflating means being especially adapted to permit unobstructed fluid flow throughout the lumen, except in the vicinity of the eye, which during inflation is closed by a blocking means, whereby the inflating means can be readily inflated free of internal constrictions even when inserted into substantially non-linear body ducts.

Accordingly, it is an object of the invention to provide a flexible drainage device having a drainage lumen of increased cross sectional area which is suitable for use in body ducts which are substantially non-linear.

It is yet another object of the invention to provide such a drainage device as a suprapubic catheter which lacks leak-producing and encumbering side arms.

Other objects and advantages will become apparent upon reference to the following drawings and detailed discussion.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a fragmentary elevational view partly in section of a catheter constructed in accordance with the invention;

FIGS. 1a and 1b illustrate a modification;

FIG. 2 is a fragmentary sectional view similar to FIG. 1 except illustrating an alternate embodiment;

FIG. 3 is a fragmentary sectional view similar to FIG. 1 and illustrating the deflation technique used with the embodiment shown in FIG. 1;

FIG. 4 is a fragmentary sectional view similar to FIG. 2 but illustrating still another embodiment;

FIG. 5 is a fragmentary sectional view similar to FIG. I but illustrating an alternate form of the deflating mechanism;

FIG. 6 is a fragmentary elevational view illustrating still another embodiment of the deflating mechanism;

FIG. 7 is a fragmentary transverse sectional view illustrating yet another embodiment of the deflating mechanism;

FIG. 8 is a fragmentary sectional view similar to FIG. 1 but illustrating yet another embodiment of the inflating mechanism; and

FIG. 9 is a fragmentary sectional view of the embodiment of FIG. 8, illustrating the deflation of the same.

DESCRIPTION OF THE PREFERRED EMBODIMENTS The particular drainage device which is set forth in the following description is a catheter for collecting urine from bladders. However, the invention should not be construed as being limited thereto but rather as directed to any drainage device for collecting liquid from body cavities wherein the drainage device utilizes an inflatable retention balloon for keeping the drainage device in place.

Referring now to FIG. 1, a catheter W constructed in accordance with the invention features a distal end 12 for insertion into a body cavity, a proximal end 14 which remains exterior to the body, and an inflatable retention balloon to adjacent to the distal end 12 and conventionally mounted on exterior surface of the catheter. In accordance with conventional practice, the catheter is a generally cylindrical tube defined by the wall 18, the interior of the all 18 forming a drainage lumen 20. This lumen extends from one or more drainage eyes 22 in the distal end 12 to theproximal end 14 for connection with urine collection means.

in accordance with one aspect of the invention, the catheter is so constructed as to permit the inflation of the balloon to by fluid flow within the drainage lumen 20 from the proximal end 14. To'accomplish this, structure is provided for blocking fluid flow out of the lumen 20 via the eyes 22. Specifically, the wall 18 under a portion of the balloon 16 has an opening 28 which permits fluid flow from the lumen 20 into retention balloon 16. A one-way flap valve 30 is positioned exteriorly to the wall 18 so as to overlie the opening 28, the valve being attached at a point 32 which is longitudinally displaced along the wall 18 from the opening 2%. This arrangement permits inflating fluid to pass from the drainage lumen 20 under the flap valve 30 and into the retention balloon in the direction indicated by arrow 34, but not in the reverse direction.

To permit the above described inflation of the retention balloon 16, it is necessary that the eyes 22 be closed off temporarily during the inflation stage. As shown in FIG. 1, this can be accomplished by means of a flap valve 40 positioned over each of the eyes on the interior side of wall 18. By this construction, pressurized flow within the lumen 20 closes the flap valve 40 to prevent leakage out through the eyes 22. On the other hand, pressure developed in the bladder after the catheter is in place causes fluid flow from the bladder through the eyes 22 and under the flap 40 into the drainage lumen 20.

It will be readily appreciated from the above description that the catheter so described has only a single lumen 20 within the walls 18, thus permitting a maximum diameter for the drainage lumen. In FIG. 1a, a tube is attached at 23 proximal to the drainage eyes 22 and overlies said eyes. Suctions applied to the proximal end of the catheter will invert the tube and pull it back to the position shown in FIG. 1b so that it no longer overlies the eyes 22 permitting immediate drainage of the bladder.

Referring now to FIG. 2, there is illustrated an altemate embodiment of the mechanism used to block the eyes during inflation of the retention balloon. Parts similar to those previously described bear the same reference numerals to which the distinguishing sufiix a" has been added. Thus, the catheter 100 has a distal end 12a wherein the eyes 22a are blocked or plugged from fluid communication between the body cavity and the drainage lumen 20a by a shield 50. The shield is formed of gelatinous material or any other substance which dissolves in urine, so that the shield is effective only for a short time when inserted, namely a time sufficient to permit the inflation of the retention balloon. Thereafter, the shield 50 dissolves and drainage automatically takes place. No particular shape of the shield 50 is necessary, and it should be recognized that an interior position of the shield within the drainage lumen 20a will function as well.

Turning now to FIG. 3, there is illustrated a method for draining the retention balloon 16a of the embodiment shown in FIG. 1. It should be recognized, however, that the drainage structure is independent of the blocking means positioned with respect to the eyes, so that the method set forth hereinafter is equally applicable to the embodiment shown in FIGS. 1 and 1a. Specifically, the drainage mechanism is that which is disclosed and claimed in our U.S. application Ser. Number 187,311, filed simultaneously herewith. That is, an overriding mechanism for the flap valve a is provided in that the walls 180 of the catheter and the flap 300 are flexible and stretchable to the point that a stretching force exerted on the distal end 12a causes the opening 28a to expend until the flap valve 30a no longer covers it. This permits drainage in the manner indicated by the arrow 52. This force can be readily exerted upon the distal end 120 by a stylet 54.

FIG. 4 illustrates yet another form of the blocking mechanism for the drainage eyes. Parts similar to those previously described bear the same reference numerals to which the distinguishing suffix b has been added. Thus, the catheter 10b has positioned between the drainage eyes 22b and the retention balloon (not shown) a one-way flap valve 60 which is centrally mounted within the drainage lumen 20b. The flap valve opens downstream so that urine can drain therethrough from the drainage eye 22b, but inflating fluid cannot be forced through the valve from the proximal end of the catheter.

FIGS. 5-7 illustrate alternate embodiments of the drainage mechanism shown in FIG. 3. Thus, FIG. 5 illustrates a catheter inflatable exactly as in previously described embodiments, wherein the walls 118 which confine the drainage lumen 120 have an additional lumen or interspace formed within the wall. The lumen 170 opens into the retention balloon 116 at one end 172 and is closed at the other end 174 approximately within the proximal end 114 of the catheter. The structure functions to drain the retention balloon when removal of the catheter is desired simply by permitting the proximal end 114 to be severed at a point which will also sever the closed end 174. Thus, no stretching of the distal end is necessary to drain balloon 116.

Referring now to FIG. 6, the structure of the catheter 210 is similar to that shown in the embodiment of FIG. 5, except that the second lumen 270 extending from the retention balloon 216 connects to an inflatable balloon or container 280 mounted at the proximal end 214 of the catheter. The balloon 280 is characterized by an inflatable surface which inflates at a lesser pressure than that required to inflate retention balloon 216. Except when drainage of the retention balloon 216 is desired, a sleeve or wrapping such as a band 284 is used to restrain temporarily the balloon 280 in a collapsed condition upon the proximal end 214. Removal of the wrapped band 284 causes the fluid pressure of the retention balloon 216 to force the fluid through the lumen 270 and into the balloon 280. Thus, balloon 280 inflates and retention balloon 216 collapses due to the removal of substantially all of the fluid therefrom.

FIG. 7 is illustrative of the cross sectional appearance of lumens which may be used in the embodiment shown in FIGS. 5 and 6 to drain the retention balloon. Lumen 270 is formed by a groove 286 in the wall 218 of the catheter with a thin layer 288 covering the groove and defining the outer wall of the lumen 270. This construction is preferably obtained during the manufacturing of the entire catheter, such as by a latex dipping process. That is, prior to the final dipping of the catheter, grooves 286 are formed in the exterior of the wall 218, and a separating material, such as tale, is painted over the groove. The final dipping then produces the layer 288 over the separating material, and thereafter the separating material is flushed or removed from the lumen 270 so formed. FIG. 7 also illustrates an alternate structure for the lumen extending from the retention balloon. Thus, lumen 370 is formed as a bubble-like extension from the wall 218. Such a lumen may be formed by a similar process as used to form lumen 270, except that no groove is formed and all but the edge portions 390 of the attachment of the layer 388 to the wall 218 are painted with a separating material prior to the final dipping.

The advantage of the lumens 179, 279 and 370 is that, as they are used only to drain the retention balloon, they need not carry substantial pressures. Thus, only the thin layers 288 and 388 are necessary to form the lumen and the lumen does not occupy or project into a portion of the drainage lumen or 120. As a result, the drainage lumen is again maintained at maxrmum size.

FIGS. d and 9 illustrate an alternate embodiment of the invention, wherein a second lumen is used both for the inflation and deflation of the retention balloon. Thus, as shown in FIG. 8, the catheter 410 features at its distal end 412, a second lumen or passageway 492' extending from the extreme end of distal end 412 to a retention balloon 416. The passageway 492 can be formed as a thin part of the wall 418 of the catheter in a manner similar to lumens 270 and 370 shown in FIG. 7, inasmuch as the length of passageway 492 is so short. The end of the passageway 492 at the distal end 412 is characterized by a one-way valve 494 formed by a slit, characterized by opposing lips 496, in the extreme distal end which opens into the drainage lumen 420. Due to the flexibility of wall 418 and the structure of valve 494, valve 494 is normally closed except when longitudinal pressure is applied in the directionof the arrow 500. Such pressure is developed when inflating fluid is injected into the drainage lumen 420. The flow of the fluid in the direction indicated by the arrow 500 causes the valve 494 to open and to permit fluid to flow along the passageway 492 and into the retention balloon 416. After the fluid is so forced into the retention balloon 416, the pressure is removed from the drainage lumen 420 so that the lips 496 close, preventing the collapse of the retention balloon. FIG. 9 illustrates one method of deflating the balloon when removal is desired. A stylet 502 having a grooved end 504 is in serted into the drainage lumen 420 so as to press in the direction indicated by the arrow 500, thus causing the one-way valve 494 to open again. This permits fluid flow from the retention balloon 416 in the reverse direction through the passageway 492, thus collapsing the balloon. A means 501 is presented for closing the drainage eyes 422 during inflation as illustrated in FIGS. 8 and 9.

Although the invention has been described in con-' nection with certain preferred embodiments, it is not intended that it be limited thereto. To the contrary, it is intended thatthe invention cover all alternate arrangements, equivalents, and embodiments as may be included within the scope of the following claims.

What is claimed is:

1. In a flexible body cavity liquid drainage device having a proximal end, a distal end, at least one drainage eye in said distal end for draining the cavity, a liquid drainage lumen extending from said eye to said proximal end, and inflatable retaining means longitudinally spaced from said eye for retaining said distal end within the body cavity; the improvement further comprising means for inflating said retaining means by fluid flowing through said lumen from said proximal end, said inflating means including means secured to said device adjacent the distal end for blocking fluid flow out through said eye and said distal end from said lumen, said inflating means permitting unobstructed fluid flow through said lumen from said proximal end to said retaining means during said inflating, whereby said inflating means can be inflated through said drainage lumen free of undesired internal constrictions even when inserted into substantially non-linear body ducts.

2. The improved drainage device as defined in claim 1, wherein said blocking means is permanently retained within said distal end.

3. The improved drainage device as defined in claim ll, wherein said blocking means includes a one-way valve positioned adjacent to said eye, said valve permitting flow into said lumen through said eye from outside said device but not in the reverse direction.

4. The improved drainage device as defined in claim- 1, wherein said blocking means comprises an external temporary shield overlying said drainage eye.

5. The improved drainage device as defined in claim 1, wherein said blocking means includes a soluble pluglike member mounted so as to temporarily block fluid flow through said eye, said member being especially adapted to dissolve after a period of time by the fluids coming into contact with said blocking means, said period being at least sufficient to permit injection of fluid into said retaining means through said lumen.

6. The improved drainage device as defined in claim 1, wherein said inflating means includes further means for blocking fluid flowing from said retaining means to said lumen, and for overriding said blocking means.

7. The improved drainage device as defined in claim 6, wherein said further blocking means includes a oneway flap valve operatively positioned between said lumen and said retaining means, and wherein said inflating means includes an opening in the wall of said device fluidly connecting said lumen with said retaining means, said valve being attached to the exterior surface of said wall at a position longitudinally displaced along said device from said opening.

8. The improved drainage device as defined in claim 7, wherein said overriding means includes at least aportion of said wall being formed of a flexible elastomeric material, whereby said opening can be altered in shape so as to extend beyond said flap valve.

9. The improved drainage device as defined in claim 1, and further including an interspace formed in the wall defining said drainage lumen and wherein said wall is characterized by a tubular shape lacking in side arm protrusions.

10. The improved drainage device as defined in claim 9, wherein said interspace is closed at one end and fluidly connected to said retaining means at its other end.

11. The improved drainage device as defined in claim 9, wherein said interspace is fluidly connected to said retaining means at one end and to a container at its other end, said container being mounted at the proximal end of said device, and further including means for temporarily restraining said container from'filling.

12." The improved drainage device as defined in claim 11, wherein said container is inflatable and is concentrically mounted with respect to said interspace, said container having an inflatable surface area which exceeds that of said retaining means, whereby in the absence of said restraining means substantially all of the fluid in said retaining means drains into said container.

13. The improved drainage device as defined in claim 1, wherein said inflating means includes, in the wall of said device defining sad drainage lumen, a passageway extending from the extreme distal end of said device to said retaining means, and a one-way valve in said extreme end permitting only controlled fluid flow in said passageway.

14. The improved drainage device as defined in claim 13, wherein said wall is formed of flexible, elastomeric material, and wherein said valve is a slit fluidly connecting said drainage lumen with said passageway, the location of said slit in the distal end and the flexibility of said walls causing said slit to be closed except when longitudinal pressure is applied to said distal end from inside said drainage lumen.

15. The improved drainage device as defined in claim 14, wherein said drainage lumen is sufficiently large to accommodate a stylet and wherein said slit is shaped so as to open when the stylet is pushed against said distal end.

16. The improved drainage device as defined in claim 1, wherein said drainage lumen is the only lumen within the walls of said device, whereby the diameter of said lumen can be maximized to the fullest extent permitted by the dimensions of the body duct into which said device is to be inserted.

17. The improved drainage device as defined in claim 2, wherein said blocking means comprises an invertible film movable upon application of suction to said lumen to an inverted position removed in a proximal direction from its eye blocking position.

t I t l 

1. In a flexible body cavity liquid drainage device having a proximal end, a distal end, at least one drainage eye in said distal end for draining the cavity, a liquid drainage lumen extending from said eye to said proximal end, and inflatable retaining means longitudinally spaced from said eye for retaining said distal end within the body cavity; the improvement further comprising means for inflating said retaining means by fluid flowing through said lumen from said proximal end, said inflating means including means secured to said device adjacent the distal end for blocking fluid flow out through said eye and said distal end from said lumen, said inflating means permitting unobstructed fluid flow through said lumen from said proximal end to said retaining means during said inflating, whereby said inflating means can be inflated through said drainage lumen free of undesired internal constrictions even when inserted into substantially non-linear body ducts.
 2. The improved drainage device as defined in claim 1, wherein said blocking means is permanently retained within said distal end.
 3. The improved drainage device as defined in claim 1, wherein said blocking means includes a one-way valve positioned adjacent to said eye, said valve permitting flow into said lumen through said eye from outside said device but not in the reverse direction.
 4. The improved drainage device as defined in claim 1, wherein said blocking means comprises an external temporary shield overlying said drainage eye.
 5. The improved drainage device as defined in claim 1, wherein said blocking means includes a soluble pluglike member mounted so as to temporarily block fluid flow through said eye, said member being especially adapted to dissolve after a period of time by the fluids coming into contact with said blocking means, said period being at least sufficient to permit injection of fluid into said retaining means through said lumen.
 6. The improved drainage device as defined in claim 1, wherein said inflating means includes further means for blocking fluid flowing from said retaining means to said lumen, and for overriding said blocking means.
 7. The improved drainage device as defined in claim 6, wherein said further blocking means includes a oneway flap valve operatively positioned between said lumen and said retaining means, and wherein said inflating means includes an opening in the wall of said device fluidly connecting said lumen with said retaining means, said valve being attached to the exterior surface of said wall at a position longitudinally displaced along said device from said opening.
 8. The improved drainage device as defined in claim 7, wherein said overriding means includes at least a portion of said walL being formed of a flexible elastomeric material, whereby said opening can be altered in shape so as to extend beyond said flap valve.
 9. The improved drainage device as defined in claim 1, and further including an interspace formed in the wall defining said drainage lumen and wherein said wall is characterized by a tubular shape lacking in side arm protrusions.
 10. The improved drainage device as defined in claim 9, wherein said interspace is closed at one end and fluidly connected to said retaining means at its other end.
 11. The improved drainage device as defined in claim 9, wherein said interspace is fluidly connected to said retaining means at one end and to a container at its other end, said container being mounted at the proximal end of said device, and further including means for temporarily restraining said container from filling.
 12. The improved drainage device as defined in claim 11, wherein said container is inflatable and is concentrically mounted with respect to said interspace, said container having an inflatable surface area which exceeds that of said retaining means, whereby in the absence of said restraining means substantially all of the fluid in said retaining means drains into said container.
 13. The improved drainage device as defined in claim 1, wherein said inflating means includes, in the wall of said device defining sad drainage lumen, a passageway extending from the extreme distal end of said device to said retaining means, and a one-way valve in said extreme end permitting only controlled fluid flow in said passageway.
 14. The improved drainage device as defined in claim 13, wherein said wall is formed of flexible, elastomeric material, and wherein said valve is a slit fluidly connecting said drainage lumen with said passageway, the location of said slit in the distal end and the flexibility of said walls causing said slit to be closed except when longitudinal pressure is applied to said distal end from inside said drainage lumen.
 15. The improved drainage device as defined in claim 14, wherein said drainage lumen is sufficiently large to accommodate a stylet and wherein said slit is shaped so as to open when the stylet is pushed against said distal end.
 16. The improved drainage device as defined in claim 1, wherein said drainage lumen is the only lumen within the walls of said device, whereby the diameter of said lumen can be maximized to the fullest extent permitted by the dimensions of the body duct into which said device is to be inserted.
 17. The improved drainage device as defined in claim 2, wherein said blocking means comprises an invertible film movable upon application of suction to said lumen to an inverted position removed in a proximal direction from its eye blocking position. 